EUROLAB
ph-eur-2616-test-for-staphylococcus-aureus-in-creams-and-gels
Pharmaceutical Microbiology Testing ICH Q10 Pharmaceutical Quality System and Microbial ControlsICH Q6A Testing for Microbiological Attributes of Drug SubstancesICH Q7 GMP Guidelines for Microbial Control in APIsICH Q9 Risk-Based Approach to Microbial ContaminationISO 11737-1 Bioburden Testing for Medical Devices and Pharmaceutical PackagingISO 11737-2 Sterility Assurance and Validation for Pharmaceutical ComponentsISO 11930 Preservation Efficacy Testing for Topical PharmaceuticalsISO 14644-1 Cleanroom Classification for Pharmaceutical ManufacturingISO 14698-1 Biocontamination Control in CleanroomsISO 16212 Yeast and Mold Testing in Pharmaceutical Raw MaterialsISO 18415 Detection of Pathogenic Microorganisms in Non-Sterile ProductsISO 21149 Enumeration of Aerobic Mesophilic Bacteria in Cosmetic and PharmaJP XVII Bacterial Endotoxin Test for Injectable PharmaceuticalsJP XVII Microbial Limit Tests for Oral PreparationsJP XVII Sterility Test for Pharmaceutical ProductsPh. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical ProductsPh. Eur. 2.6.11 Detection of Pathogens in Veterinary PharmaceuticalsPh. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile ProductsPh. Eur. 2.6.13 Detection of Clostridia in Parenteral SolutionsPh. Eur. 2.6.14 Bacterial Endotoxins – Gel Clot MethodPh. Eur. 2.6.15 Test for Pseudomonas aeruginosa in Topical DrugsPh. Eur. 2.6.2 Mycoplasma Detection in Cell-Based PharmaceuticalsPh. Eur. 2.6.25 Testing for Anaerobic Bacteria in Sterile ProductsPh. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral DrugsPh. Eur. 2.6.30 Monitoring of Controlled EnvironmentsPh. Eur. 2.6.32 Control of Bacterial Contamination in Ophthalmic DrugsPh. Eur. 2.6.7 Mycobacteria Detection in BiopharmaceuticalsPh. Eur. 2.6.9 Test for Escherichia coli in Non-Sterile PharmaPh. Eur. 5.1.4 Microbiological Quality of Pharmaceutical PreparationsPh. Eur. 5.1.6 Alternative Methods for Microbiological Quality ControlPh. Eur. 5.1.8 Bioburden Limits in Parenteral ManufacturingUSP <1072> Disinfectants and Antiseptics Microbial Efficacy TestUSP <1111> Microbiological Examination of Non-Sterile ProductsUSP <1115> Bioburden Control of Non-Sterile Drug SubstancesUSP <1116> Microbiological Control of Clean Rooms and Controlled EnvironmentsUSP <1117> Microbial Best Practices for Pharmaceutical Lab PersonnelUSP <1207> Package Integrity Evaluation – Microbial Ingress TestUSP <1208> Integrity Testing for Sterile Barrier SystemsUSP <1223> Water Activity Determination in Drug ProductsUSP <1227> Validation of Microbial Recovery MethodsUSP <1229> Microbial Quality of Compendial Water SystemsUSP <1231> Water for Pharmaceutical Purposes – Microbiological TestingUSP <39> Bioburden Limit Testing for Bulk Active IngredientsUSP <39> Microbiological Quality of Compounding PharmaciesUSP <51> Preservative Effectiveness Testing of Multi-Dose PharmaceuticalsUSP <55> Biological Indicators for Sterilization ValidationUSP <61> Microbial Enumeration Tests for Raw Pharmaceutical MaterialsUSP <61>/<62> Microbial Limit Tests for Tablet and Capsule FormsUSP <62> Tests for Specified Microorganisms in Non-Sterile ProductsUSP <71> Sterility Testing of Injectable Pharmaceutical Products

Ph. Eur. 2.6.16 Test for Staphylococcus aureus in Creams and Gels: Laboratory Testing Services Provided by Eurolab

Standard-Related Information

The Ph. Eur. 2.6.16 Test for Staphylococcus aureus in Creams and Gels is a laboratory testing service that involves the detection of Staphylococcus aureus, a type of bacteria commonly found on human skin, in creams and gels. This test is governed by various international and national standards, including:

  • Ph. Eur. 2.6.16: Detection of staphylococci (2008)

  • ISO 11133: Microbiology of food and animal feeding stuffs - Part 1: General guidance on methods (2014)

  • ASTM E2197-13: Standard Test Method for Staphylococcus aureus in Skin Care Creams and Gels

  • EN 14562-3: Sterilization of medical instruments - Microbiological control - Part 3: Validation of sterilization processes by biological indicators

    • These standards outline the requirements for testing, sample preparation, equipment calibration, and result interpretation. The Ph. Eur. 2.6.16 test is a critical component in ensuring the quality and safety of creams and gels used in personal care products.

    Standard Requirements and Needs

    The Ph. Eur. 2.6.16 Test for Staphylococcus aureus in Creams and Gels is necessary to ensure that these products are free from contamination with pathogenic microorganisms, including Staphylococcus aureus. This test helps:

  • Prevent the spread of infections

  • Maintain product quality and safety

  • Comply with regulatory requirements

  • Meet customer expectations

    • Business and technical reasons for conducting this test include:

  • Ensuring compliance with international standards and regulations

  • Maintaining a competitive edge in the market

  • Protecting brand reputation and customer trust

  • Reducing risk of recalls, legal actions, and financial losses

    • Test Conditions and Methodology

    The Ph. Eur. 2.6.16 Test for Staphylococcus aureus in Creams and Gels involves the following steps:

    1. Sample preparation: The test sample is prepared according to Ph. Eur. guidelines.

    2. Inoculation: A known quantity of Staphylococcus aureus is added to the test sample.

    3. Incubation: The inoculated sample is incubated at a controlled temperature (37C 1C) for 24-48 hours.

    4. Microbial enumeration: The number of colonies formed is counted and compared with a standard curve.

    The testing equipment used includes:

  • Incubators

  • Microscopes

  • Microplate readers

    • Test Reporting and Documentation

    Results are documented in a test report that includes the following information:

  • Test sample details

  • Result values (e.g., colony-forming units per milliliter)

  • Reference to relevant standards and regulations

  • Conclusion and recommendations for future testing

    • Reporting formats include:

  • Standardized test reports

  • Electronic reporting systems

    • Why This Test Should Be Performed

    Performing the Ph. Eur. 2.6.16 Test for Staphylococcus aureus in Creams and Gels offers numerous benefits, including:

  • Risk assessment and mitigation through testing

  • Compliance with regulatory requirements

  • Quality assurance and compliance benefits

  • Competitive advantages and market positioning

    • Why Eurolab Should Provide This Service

    Eurolab is uniquely qualified to provide this service due to its:

  • Expertise in microbiological testing

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

    • Conclusion

    The Ph. Eur. 2.6.16 Test for Staphylococcus aureus in Creams and Gels is a critical laboratory testing service that ensures the quality and safety of creams and gels used in personal care products. Eurolabs expertise, facilities, and personnel make it an ideal provider of this service.

    References

  • Ph. Eur. 2.6.16: Detection of staphylococci (2008)

  • ISO 11133: Microbiology of food and animal feeding stuffs - Part 1: General guidance on methods (2014)

  • ASTM E2197-13: Standard Test Method for Staphylococcus aureus in Skin Care Creams and Gels

  • EN 14562-3: Sterilization of medical instruments - Microbiological control - Part 3: Validation of sterilization processes by biological indicators

    • Tables and Figures

    Table 1: Ph. Eur. 2.6.16 test standards and guidelines

    Figure 1: Staphylococcus aureus growth curve

    Appendix

  • Glossary of terms

  • Common errors in sample preparation

  • Recommendations for future testing

    • Need help or have a question?
    Contact us for prompt assistance and solutions.

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